Pharmacovigilance assessments: challenges and solutions for pharmacovigilance assessors
Event
Pharmacovigilance
Date
- Monday, 11 November 2019, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
This training is organised for pharmacovigilance assessors in the European Union and the European Economic Area and delegates from the Pharmacovigilance Risk Assessment Committee (PRAC) who assess pharmacovigilance procedures at their national competent authorities.
It covers:
- pharmacovigilance assessments and its challenges and solutions;
- the safe use of medicines during pregnancy and lactation;
- ways of gathering data via post-authorisation safety studies;
- assessing advanced therapies;
- assessing drug-induced liver injury.
Participation in this training is also possible via webinar.
A limited number of places is available for non-EU regulators that have confidentiality agreements in place with EMA, on a first come, first served basis. Please note that EMA does not offer financial support for the participation of non-EU regulators in this event.